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临床试验/NCT06483880
NCT06483880招募中不适用

The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection: a Randomised Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Recurrence of pulmonary hydatid disease

研究概览

简要总结

The aim of this study is to study the role of adjuvant Albendazole after pulmonary hydatid cyst resection versus placebo in reducing recurrence with a short- term follow-up of six months.

详细描述

Hydatid disease, also referred to as cystic echinococcosis, is a major zoonotic disease with global distribution caused by the larval stage of the Echinococcus parasite, which belongs to the Taeniidae family and Echinococcus genus.

Cystic Echinococcosis is prevalent in several regions across the globe, including Mediterranean countries, southern America, Australia, eastern and northern Africa, as well as the Tibetan terrain of Asia.

Dogs and other members of the canid family serve as definitive hosts, as they harbor adult tapeworms within their intestinal tract and excrete parasite eggs in their feces. The intermediate hosts, which encompass a wide range of mammalian species including humans, can get accidentally infected through the ingestion of eggs via food or water that has been contaminated. Upon ingestion of tapeworm eggs found in the feces of dogs, the embryos are liberated from the eggs, traverse the intestinal mucosa, and disseminate to various organs via the bloodstream. The liver accounting for 60% to 70% of infections, and the lungs, comprising around 20% to 30% of infected cases, are the organs most frequently affected by infection.

Surgery is the gold standard treatment to get rid of a pulmonary hydatid cyst, though in some rare cases chemotherapy may be necessary. Despite claims that very small cysts can disappear on their own, surgery remains the gold standard for treating hydatid cysts. Re-surgery after recurrence is associated with increased operative morbidity and mortality. Surgical intervention may sometimes be required due to the development of complications in patients who receive only medical treatment.

Mebendazole was initially used for the therapeutic treatment of the hydatid cyst. Nevertheless, the drug's uptake from the gastrointestinal tract was poor, prompting its substitution with albendazole, which has better absorption. The drug's activity is enhanced by its metabolite, albendazole sulfoxide, which readily diffuses through the cyst membrane and accumulates in the cyst fluid. It has been shown that adjuvant albendazole treatment is effective in reducing recurrence postoperatively in liver hydatidosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients regardless of age with pulmonary hydatid disease requiring surgical resection.
  • Patients achieving complete resection of pulmonary hydatid disease.
  • Patients with no extra pulmonary hydatid disease.
  • Patients who have received preoperative albendazole.

排除标准

  • Patients with extra pulmonary hydatid disease requiring treatment after pulmonary resection.
  • Patients with incomplete resection of pulmonary hydatid disease.
  • Patients with pulmonary hydatid disease not amenable for resection.
  • Patients with hypersensitivity to Albendazole.
  • Patients with liver dysfunction.
  • Patients refusing to be enrolled in the study.

研究组 & 干预措施

Albendazole arm

Active Comparator

The administration of albendazole therapy is recommended at a dosage of 15 mg/kg/day, given in two equally split doses per day. This is within two 15-day cycles following surgery.

干预措施: Albendazole (Drug)

Placebo arm

Placebo Comparator

Patients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery.

干预措施: Placebo (Drug)

结局指标

主要结局

Recurrence of pulmonary hydatid disease

时间窗: six months

Recurrence of pulmonary hydatid disease in six months in both groups, assessed by: 1. Chest X-ray radiography after the 2 weeks. 2. CT chest in six months and after one year or symptoms requiring CT chest at any timing.

次要结局

  • Financial cost between both groups.(Six months)
  • In hospital mortality between both groups.(Six months)
  • Liver function tests (AST and ALT) between both groups.(Six months)
  • Length of hospital stay between both groups.(Six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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